MedTrace Logo

Continuous Glucose Monitoring in Diabetes and Prediabetes

NCT03805412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-03-01

Study results available
· View outcomes & findings →

Summary

Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM, nutrition and exercise education, participants will be able to monitor their blood sugar in real time for 2 sessions . Education on how to interpret CGM in the setting of food choices and exercise coupled with nutrition and exercise information should lead to improved weight and other nutritional and exercise changes.

Conditions

Interventions

DEVICE

DEXCOM G6 RT-CGM

CGM is a way to measure glucose levels in real-time. A tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. A small plastic piece of tube remains inserted in the skin. It is connected to a transmitter that sits on top of the skin. It is approved for use on the abdomen for 10 days. It either records the sugars downloaded in the clinic (blinded part of the study) or it sends the information via wireless radio frequency to a monitoring/ display device or to a cellular phone so participants can see data. DEXCOM G6 is FDA approved for use in patients with diabetes and will be used in accordance with instructions as approved for diabetes.

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Nicole Ehrhardt, MD

    lead OTHER

Principal Investigators

  • Nicole Ehrhardt, MD · George Washington University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-10
Primary Completion
2020-07-03
Completion
2020-07-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03805412 on ClinicalTrials.gov